Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy - Full Text View

Sponsor:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00113620

Purpose

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Condition	Intervention	Phase
Pain Diabetic Neuropathy	Drug: Neurodex	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Quinidine sulfate Quinidine Dextromethorphan hydrochloride Quinidine polygalacturonate Avp 923 Levomethorphan Dextromethorphan Racemethorphan Dextromethorphan hydrobromide

U.S. FDA Resources

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:

Pain rating scale obtained from patient diaries

Secondary Outcome Measures:

Additional diary rating scales and scores obtained from clinic visits

Estimated Enrollment:	450
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of diabetes mellitus
Established diabetic therapy for at least 3 months
Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
Pain the previous three months
Not pregnant

Exclusion Criteria:

Patient failed adequate trial of 3 or more medications or has required narcotics for pain
History of torsades de pointes
Sensitivity to quinidine or opiate drugs (codeine, etc)
Severe pain that could confound the assessment
Patient has had any amputations
Patient has participated in the past 30 days or is currently participating in another trial
Patient has previously received treatment with dextromethorphan and quinidine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113620

Hide Study Locations

Locations

United States, Arizona
Pivotal Research Centers
Mesa, Arizona, United States, 85210
Dedicate Clinical Research, Inc.
Sun City, Arizona, United States, 85351
United States, Arkansas
Research Solutions
Jonesboro, Arkansas, United States, 72401
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, California
Pacific Sleep Medicine Services, Inc.
Palm Springs, California, United States, 92262
South Bay Clinical Research Inc.
Inglewood, California, United States, 90301
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Northern California Research Group
Sacramento, California, United States, 95831
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States, 90048
Bay Area Foot Care
Castro Valley, California, United States, 94546
United States, Florida
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
University Clinical Research - DeLand
DeLand, Florida, United States, 32720
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
Laszlo J. Mate, MD
West Palm Beach, Florida, United States, 33407
Neurology Clinical Research, Inc.
Sunrise, Florida, United States, 33351
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Indiana
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
Investigative Clinical Reserach of Indiana, LLC
Indianapolis, Indiana, United States, 46254
United States, Maryland
Crossroads Research, Inc.
Owings Mills, Maryland, United States, 21117
United States, Missouri
Radiant Research - St. Louis
St. Louis, Missouri, United States, 63141
Medex Healthcare Research, Inc.
St. Louis, Missouri, United States, 63117
United States, Montana
Montana Neuroscience Institute
Missoula, Montana, United States, 59802
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Weill Medical College of Cornell University - Peripheral Neuropathy Center
New York, New York, United States, 10022
DiGiovanna Family Care Center
Great Neck, New York, United States, 11021
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
United States, North Carolina
Vital Research
Greensboro, North Carolina, United States, 27408
United States, Ohio
Radiant Research - Akron
Mogadore, Ohio, United States, 44260
Radiant Research
Cincinnati, Ohio, United States, 45236
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Knights Road Medical
Bensalem, Pennsylvania, United States, 19020
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research - Greer
Greer, South Carolina, United States, 29651
United States, Texas
Radiant Research
Dallas, Texas, United States, 75231
SAM Clinical Research
San Antonio, Texas, United States, 78229
Diabetes & Glandular Disease Research Assoc.
San Antonio, Texas, United States, 78229
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
United States, Virginia
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23451
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	04-AVR-109
Study First Received:	June 9, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00113620 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

distal symmetrical
pain
lower extremities
dextromethorphan

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Antiprotozoal Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Cholinergic Agents
Antimalarials
Antiparasitic Agents
Neuromuscular Diseases
Therapeutic Uses
Anti-Arrhythmia Agents

Diabetes Complications
Excitatory Amino Acid Antagonists
Diabetic Neuropathies
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Adrenergic alpha-Antagonists
Pharmacologic Actions
Muscarinic Antagonists
Quinidine
Peripheral Nervous System Diseases
Dextromethorphan
Adrenergic Antagonists

ClinicalTrials.gov processed this record on November 22, 2009